The Innovative Medicines Initiative (IMI)

The IMI Call and Evaluation Process

Eva Lindgren

• Rules for participation• Eligibility for funding• Rules for submission• Call process

– Description of call topics– Submission of expressions of interest– Submission of full project proposals– Peer review evaluation

• Timelines• Topics

Agenda

Rules for Participation in IMI Consortia

• Any entity carrying out work relevant to the IMI JU in a Member State or country associated with the 7th Framework Programme

• Anyone else with the agreement of the IMI JU

BUT

• Not all participating entities are eligible for funding

Eligible Consortia

• The IMI JU supports consortia who submit applications in response to a call

• Consortia must contain:– At least 2 legal entities eligible to receive

funding– At least 2 research-based pharmaceutical

companies who are members of EFPIA– All 4 entities must be independent of each

other

Eligibility for IMI funding

Eligible for funding

Non-eligible for funding

– Academia– SMEs (EU

definition)– Patient

Organisations– Other non-for-

profit legal entities

– EFPIA companies – Other companies

not falling within the EU definition of SMEs

Direct eligible costs

• Actual• Incurred by the claimant• Incurred during the project• Incurred for work in a Member State

or country associated with FP7• Incurred for the achieving the

objectives of the project

Total eligible costs

Direct Eligible Costs

These apply equally to all participants - to those who receive funding and to the EFPIA participants to calculate their in-kind contribution

Indirect Costs (max 20% of Direct Eligible Costs, excl.

subcontracting)

Upper Funding Limits(for participants eligible for funding by IMI JU)

Research ActivitiesMaximum 75% of total eligible costs

Other Activities, including Management and Training ActivitiesMaximum 100%of total eligible costs

IMI Call Process is Different from the 7th Framework Programme Process

1. Research topics are approved by the IMI Governing Board (EFPIA and European Commission) based on proposals from the EFPIA Research Directors Group and after consultation with IMI Member State Representatives & IMI Scientific Committee

2. A private consortium (the EFPIA Consortium) is established for each topic & a coordinator and deputy are proposed who will lead the full Consortium

IMI Call Process is Different from the 7th Framework Programme Process

3. Applicant Consortia submit Expressions of Interest without the involvement and participation of the EFPIA Consortia (stage 1)

4. For each topic, the best selected Applicant Consortium joins the EFPIA Consortium to form a Full Project Consortium

5. The Full Project Consortium submits a Full Proposal to stage 2 of the peer review process

Call

Research Agenda

Call Topics

Annual Implementation Plan

Call definition

Call & Evaluation ProcessCall definition

Description of the Call Topics

1. Title

2. Project description

3. Key deliverables of the project

4. EFPIA member companies participating in the project

5. Role of EFPIA participants in the project

6. Duration of the project

7. Total in kind contribution from the EFPIA member companies

8. Expectations from the Applicant consortium (science and budget guideline)

Description of the call topics

• IMI research projects will often be multidisciplinary and addressing translational medicine challenges

• Integrated approaches between non-clinical and clinical disciplines are often required

• The successful Applicant Consortium is expected to include expertise for all aspects of the areas mentioned in the description of the call topics

Call

Research Agenda

Call Topics

Annual Implementation Plan

Call definition

Expression of Interest

1st Peer Review

Invitation to Submit Full Project Proposal

Stage 1: Scientific excellence

Call & Evaluation ProcessStage 1

≈ 5 months

Description of the Expression of Interest

1. Scientific Case1. Approaches to meet the project objectives (2 pages)

2. Composition of the Applicant Consortium (1/2 page per member)

3. Unique features and complementarities of the Consortium (1 page)

4. Summary work plan (2 pages)

2. Declaration of ethical issues (1/2 page)

3. Provisional budget plan1. Estimated cost per Consortium member

2. Estimated requested IMI contribution

Written by the Applicant Consortium: i.e. academia, SMEs, regulators, patients organisations (without EFPIA)

Peer Review - Stage 1

• Peer Review Committees– Ad hoc experts relevant to the call topics – EFPIA Consortia co-ordinators participate in

evaluation of Expressions of Interest – For 2009 and beyond, Standing Peer Review

Committees (one per Pillar of the Strategic Research Agenda) assisted by ad hoc experts

• Responsibility– To evaluate science of Expressions of Interest

and select the winning Applicant Consortiumfor each topic

• Decision Making– By consensus between all experts

Evaluation of the Expressions of Interest

Four categories that will be scored:• Scientific and/or technological excellence• Partnership Case• Quality of the Applicant consortium as a whole• Quality and soundness of the work plan, including

budget

First two will have thresholds

One category that will not be scored:• Any other remarks including ethical issues

Call

Research Agenda

Call Topics

Annual Implementation Plan

Call definition

Expression of Interest

1st Peer Review

Invitation to Submit Full Project Proposal

Stage 1: Scientific excellence

Full Project Proposal

2nd Peer Review

Stage 2: Feasibility and scientific excellence

Call & Evaluation ProcessStage 2

≈ 5 months

≈ 3 months

Description of the Full Project Proposal

• Written jointly by the members of the EFPIA Consortium and the winning Applicant Consortium

• Full description of research activities– What, who, when, and how much

• Will need a draft Project Agreement before submission– IPR sharing agreed between all partners

• Expectation of high probability of success

Written by the Full Project Consortium: i.e. academia, SMEs, patients organisations with EFPIA companies

Peer Review Stage 2

• Peer Review Committees– Ad hoc experts relevant to the call topics

• Same as reviewed the Expressions of InterestBUT• Addition of experts on ethics as needed• No involvement of EFPIA Consortia co-ordinators

• Responsibility– To evaluate Full Proposals based on science and

feasibility

• General– Consensus decisions, Standing Peer Review

Committees foreseen for future years

Evaluation of the Full Project Proposal

Evaluation will likely include consideration of the following aspects:

– Scientific and/or technological excellence– Consistency with the original Expression of Interest

• Scope and composition of the consortia– Project implementation plan– Draft Project Agreement– Potential impact of the project results

Categories will be graded Excellent, Acceptable (subject to adjustment to points raised), or Non-acceptable

Call

Research Agenda

Call Topics

Annual Implementation Plan

Call definition

1. Project Agreement2. Grant Agreement Contract

Execution

Call & Evaluation Process

Expression of Interest

1st Peer Review

Invitation to Submit Full Proposal

Stage 1: Scientific excellence

≈ 5 months

Full Project Proposal

2nd Peer ReviewStage 2: Feasibility and scientific excellence

≈ 3 months

≈ 2 months

Tentative timelines for First Call

May June July August Sept October Nov. Dec. January February

Publication of Call

Submission period for Expressions of Interest

Evaluation Stage 1

Submission period for Full proposals

Evaluation Stage 2

Negotiation, signature of Grant Agreements, first payments

April 30th July 15th

Topics for the First Call

1. Improved predictivity of immunogenicity 13m/ 5y

2. Non-genotoxic carcinogenesis 2.5m/2y plus 10m/ 3y 3. Expert systems for in silico toxicity prediction 5m/ 5y4. Improved predictivity of non-clinical safety evaluation 10m/ 3y 5. Qualification of Translational safety biomarkers 21m/ 5y6. Strengthening the monitoring of benefit/risk 15m/ 5y7. Islet cell research 10m/ 5y8. Surrogate markers for vascular endpoints 20m/ 5y9. Pain research 7.5m/ 5y10. New tools to develop novel therapies in psychiatric disorders 10m/

5y11. Neurodegenerative disorders 7.5m/ 5y12. Understanding severe asthma 12.5m/ 5y13. COPD Patient Reported Outcomes 2m/ 1y +

8m/5y14. European Medicines Research Training Network 5m/ 7y15.Safety sciences for medicines training programme 3m/ 5y16. Pharmaceutical medicine training programme 4m/ 5y17. Integrated medicines development training programme 3m/ 5y18. Pharmacovigilance training programme 3.5m/ 5y

EFPIA Commitment: 172.5m Euros, typical project ~15m,

5-10 EFPIA partners/project, majority of 5y duration

The Innovative Medicines Initiative (IMI)

First Call for Proposals published:http://imi.europa.eu

Deadline for Expressions of Interest:15 July 2008

Back ups

www.imi.europa.euwww.imi-europe.org

Strong industry commitmentStrong Industry Commitment

€172.5m

# 2008 Call Topics Companies In-kind (m)

1 Improve Predictivity of Immunogenicity 12 €13

2 Non-genotoxic Carcinogenesis 8 €12,5

3 Expert Systems for in silico Toxicity Prediction 10 €5

4 Improved Predictivity of non-clinical Safety Evaluation 11 €10

5 Qualification of Translational Safety Biomarkers 12 €21

6 Strengthening the Monitoring of Benefit/Risk 15 €15

7 Islet Cell Research 11 €10

8 Surrogate Markers for Vascular Endpoints 7 €20

9 Pain Research 12 €7,5

10 New Tools for the Development of Novel Therapies in Psychiatric Disorders

13 €10

11 Neurodegenerative Disorders 14 €7,5

12 Understanding Severe Asthma 10 €12,5

13 COPD Patient Reported Outcomes 9 €10

14 European Medicines Research Training Network 24 €5

15 Safety Sciences for Medicines Training Programme 24 €3

16 Pharmaceutical Medicine Training Programme 24 €4

17 Integrated Medicines Development Programme 24 €3

18 Pharmacovigilance Training Programme 24 €3,5

Funding will be allocated to IMI projects until 2013 but research will be supported until 2017

0

100

200

300

400

500

600eu

ros

mill

ion

s

2008 2009 2010 2011 2012 2013

Total AnnualBudget